NCT07519928

Brief Summary

The goal of this clinical study is to determine the feasibility and explore the potential benefits of pelvic floor muscle training during inpatient SCI rehabilitation on urinary, bowel, and sexual function and quality of life in people with SCI. The main questions it aims to answer are:

  1. 1.What is the feasibility of recruiting inpatients from SCI rehabilitation to a pelvic floor muscle training program?
  2. 2.What is the feasibility and acceptance of the implementation of a pelvic floor muscle training program in SCI inpatient rehabilitation?
  3. 3.What are the potential effects of a pelvic floor muscle training program implemented in SCI inpatient rehabilitation on bladder, bowel, and sexual function and quality of life?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Mar 2028

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 2, 2026

Last Update Submit

April 11, 2026

Conditions

Keywords

Spinal Cord InjuryPhysiotherapyPhysical TherapyPelvic Floor Muscles

Outcome Measures

Primary Outcomes (3)

  • Feasibility - Recruitment Rate

    Recruitment Rate will be evaluated by the number of participants approached, screened for eligibility, and invited to enroll in the study, relative to the number of overall inpatients admitted to the GF Strong Rehabilitation Center SCI unit. We will document the number of participants who enrolled, declined enrollment, or did not respond to our invitation to enroll, as well as the reasons for not enrolling when available.

    Through study completion, an average of 8 months

  • Feasibility - Compliance

    Compliance will be tracked by the number of participants who underwent the intervention, as well as their adherence to the prescribed exercise program (attendance to supervised sessions and diaries), with reasons for missed sessions or drop-outs noted.

    Through study completion, an average of 8 months

  • Feasibility - Acceptability (Perceived Acceptability Questionnaire)

    Acceptability of the intervention will be assessed using a study-specific questionnaire, the Perceived Acceptability Questionnaire, developed for this study. The questionnaire aims to capture participants' enjoyment of the PFMT program and their perceptions of its benefits for urinary, bowel, and sexual health. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), with higher scores reflecting greater perceived acceptability and benefit.

    Through study completion, an average of 8 months

Secondary Outcomes (10)

  • Incontinence Quality of Life Questionnaire (I-QoL)

    Through study completion, an average of 8 months

  • Neurogenic Bladder Symptoms Score (NBSS)

    Through study completion, an average of 8 months

  • Timed Bowel Routine

    Through study completion, an average of 8 months

  • Neurogenic Bowel Dysfunction Score (NBDS)

    Through study completion, an average of 8 months

  • International Index of Erectile Function (IIEF) Questionnaire

    Through study completion, an average of 8 months

  • +5 more secondary outcomes

Study Arms (1)

Pelvic Floor Muscle Physical Therapy

EXPERIMENTAL

Pelvic floor muscle physical therapy 5/week for 6 weeks.

Behavioral: Pelvic Floor Muscle Physiotherapy

Interventions

Pelvic floor muscle physiotherapy 5x/week for 6-weeks.

Pelvic Floor Muscle Physical Therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are at least 19 years of age.
  • Have a traumatic or non-traumatic SCI
  • Are able to perform a voluntary anal contraction
  • Present with bladder or urinary tract dysfunction from SCI
  • Are a current inpatient at GF Strong Rehabilitation Center and are expected to remain as an inpatient for at least 6 weeks after the time of consent.
  • Are able to speak and understand English.

You may not qualify if:

  • Present with symptoms of lower motor neuron injury to the sacral segments (e.g. negative anal and bulbocavernosus reflexes)
  • Present with any other condition besides SCI that impacts the pelvic floor muscles or other pelvic structures
  • Are planning to receive intra-detrusor Botox injections in the next 3 months
  • Have a brain injury or other condition that interferes with their ability to follow instructions
  • Are using a ventilator
  • Have severe and unmanaged spasticity (involuntary muscle tightness or spasms) or contractures (prolonged muscle/joint stiffness)
  • Are unable to tolerate transfers to or lie on a physical therapy table
  • Experience severe pain that interferes with their ability to participate in pelvic floor muscle training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations